Vice President, Data Management (Fully Remote)

Prilenia; United States; Remote; USD 180,000 - 240,000; Full time

Job summary

Prilenia is seeking an senior leader to steer clinical data management across the portfolio. You will own data management planning, design of CRFs, data validation, and database integrity to withstand regulatory scrutiny.

The role requires directing CRO/EDC/CDMS partnerships, ensuring alignment with NDA/MAA timelines, and driving standards such as CDISC to support high-quality submissions.

Qualifications

• Lead data management strategy and execution across a clinical portfolio.
• Partner with regulatory and submission teams to align data management with NDA/MAA timelines.
• Strong leadership and cross-functional collaboration skills.

Responsibilities

• Develop and execute clinical data management strategy aligned with regulatory timelines.
• Oversee Data Management Plans, CRF/eCRF design, and data validation plans.
• Manage data management CROs, EDC vendors, and budget oversight.

Job description

• Lead the strategy, build-out, and execution of clinical data management across the portfolio.
• Own data management planning, EDC systems, data standards, database lock, and CRO/vendor oversight.
• Ensure clinical database withstands Regulatory Authority scrutiny, including pre-approval inspection.

Key Responsibilities:

• Develop and execute clinical data management strategy aligned with regulatory timeline and submission milestones.
• Oversee development of Data Management Plans, CRF/eCRF design, and data validation plans.
• Manage relationships with data management CROs, EDC vendors, and specialty data vendors, including scope and budget.

Qualifications:

• Advanced degree in life sciences, health informatics, statistics, or related field; 12+ years of progressive clinical data management experience.
• Direct experience leading data management through at least one successful NDA, BLA, or MAA submission.
• Deep working knowledge of CDISC standards and hands-on experience with major EDC/CDMS platforms.

Prilenia is a private biopharmaceutical company focused on bringing transformative medicines to people with neurodegenerative diseases such as ALS and Huntington's disease. They are a small to mid-size clinical-stage organization with a highly committed global team and a flexible, mostly remote culture.